Publications

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

Hogan Lovells Publications

Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...

Hogan Lovells Publications

FDA releases working model for Software Precertification Pilot Program

Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its ...

Hogan Lovells Publications

FDA signals increasing focus on cybersecurity requirements

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical...

Hogan Lovells Publications

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections...

Hogan Lovells Publications

CDRH's "Critical to Quality" PMA pilot program opens to applicants today

The U.S. Food and Drug Administration’s recently announced voluntary Premarket Approval Application (PMA) “Critical to Quality” pilot program opens to applicants today.

Hogan Lovells Publications

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office...

Hogan Lovells Publications

A "Cure" for Combination Products: 21st Century Cures Act Mandates Greater Transparency of Combination Product Designations

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat...

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